315 results
Keyword levonorgestrel Remove keyword
-
List item
Referral: Levonelle 1500 microgram tablets and associated names
levonorgestrel, Article 13 referrals
Status: European Commission final decision, opinion/position date: 26/05/2016, EC decision date: 01/08/2016, Last updated: 09/08/2016contraceptive Levonelle (levonorgestrel, 1500 microgram tablets … method. Levonelle contains levonorgestrel, which works mainly by preventing … containing 1500 microgram levonorgestrel or as two tablets each containing … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Levonorgestrel, Route(s) of administration: Intrauterine use, Pharmaceutical form(s): Intrauterine delivery system
Decision date: 05/05/2010, Last updated: 22/07/2010, Compliance check: XLevonorgestrel Endocrinology-Gynaecology-Fe … Levonorgestrel … granting of a waiver for levonorgestrel (EMEA-000606-PIP01-09) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002474-PIP02-18, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: XActive substance levonorgestrel Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … levonorgestrel … -
List item
Referral: Seasonique and associated names
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 12/01/2015, Last updated: 29/01/2015takes the tablets containing levonorgestrel and ethinylestradiol and … containing only ethinylestradiol. Levonorgestrel (a progestogen) and ethinylestradiol … Seasonique and associated names (levonorgestrel / ethinylestradiol) PDF icon … -
List item
Referral: Rigevidon
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2005, EC decision date: 10/05/2005, Last updated: 08/06/2005contraceptive (COC) containing 150μg levonorgestrel (LNG) and 30μg ethinylestradiol … Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol: Background … Rigevidon, INN-levonorgestrel and ethinylestradiol … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Anastrozole, levonorgestrel
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001575-PIP01-13, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 02/05/2014, Last updated: 06/06/2014, Compliance check: XActive substance Anastrozole levonorgestrel Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … waiver for anastrozole / levonorgestrel (EMEA-001575-PIP01-13 … waiver for anastrozole / levonorgestrel (EMEA-001575-PIP01-13) in … -
List item
Referral: Emergency contraceptives
levonorgestrel, ulipristal acetate, associated names: Norlevo, Levonelle/Postinor and Levodonna, ellaOne, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2014, EC decision date: 30/09/2014, Last updated: 24/10/2014September 2014 EMA/631408/2014 Levonorgestrel and ulipristal remain suitable … contraceptives containing levonorgestrel or ulipristal acetate to … contraceptive containing levonorgestrel, Norlevo, was updated on the … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel, ethinylestradiol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000829-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/07/2010, Last updated: 26/08/2010, Compliance check: XActive substance levonorgestrel ethinylestradiol Therapeutic … product specific waiver for levonorgestrel/ethinylestradiol (EMEA-000829-PIP01- 09 … product specific waiver for levonorgestrel/ethinylestradiol (EMEA-000829-PIP01- 09 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Estetrol, levonorgestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001513-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XActive substance Estetrol levonorgestrel Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … a waiver for estetrol / levonorgestrel (EMEA-001513-PIP01-13) in … a waiver for estetrol / levonorgestrel (EMEA-001513-PIP01-13) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Prasterone, levonorgestrel, ethinylestradiol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002960-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 08/09/2021, Last updated: 11/01/2023, Compliance check: XActive substance Prasterone levonorgestrel ethinylestradiol Therapeutic … specific waiver for prasterone / levonorgestrel / ethinylestradiol (EMEA- 002960-PIP02-21 … specific waiver for prasterone / levonorgestrel / ethinylestradiol (EMEA- 002960-PIP02-21 … -
List item
Press release: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
CHMP, Last updated: 24/07/2014Levonorgestrel and ulipristal remain suitable … Levonorgestrel and ulipristal remain suitable … Levonorgestrel and ulipristal remain suitable … -
List item
Human medicine European public assessment report (EPAR): ellaOne
ulipristal, Contraception, Postcoital
Date of authorisation: 15/05/2009, Revision: 28, Authorised, Last updated: 19/04/2023study compared ellaOne with levonorgestrel (another medicine used in … ellaOne was as effective as levonorgestrel at preventing pregnancies … study compared ellaOne with levonorgestrel (another medicine used in … -
List item
Press release: Review of emergency contraceptives started
CHMP, Last updated: 24/01/2014the European Union contain levonorgestrel or ulipristal acetate. The … contraceptive medicines containing levonorgestrel or ulipristal acetate … the European Union contain levonorgestrel or ulipristal acetate. The … -
List item
Press release: EMA recommends availability of ellaOne emergency contraceptive without prescription
CHMP, Last updated: 21/11/2014profile is comparable to levonorgestrel-containing emergency contraceptives … contraceptives in the EU. Levonorgestrel-containing emergency contraceptives … profile is comparable to levonorgestrel-containing emergency contraceptives … -
List item
Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014containing the progestogens levonorgestrel, norethisterone or norgestimate … containing the progestogens levonorgestrel, norethisterone or norgestimate … Women using a CHC containing levonorgestrel, norethisterone or norgestimate … -
List item
Press release: Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation
CHMP, Last updated: 22/11/2013containing the progestogens levonorgestrel, norethisterone or norgestimate … containing the progestogens levonorgestrel, norethisterone or norgestimate … Women using a CHC containing levonorgestrel, norethisterone or norgestimate … -
List item
Combined hormonal contraceptives
Last updated: 22/11/2013levonorgestrel, norethisterone …
-
List item
National expert: Kimmo Jaakkola, Finnish Medicines Agency (updated)
- Declaration of interests - 39.4 KB | PDF
- Curriculum Vitae - 27.13 KB | PDF
Koskenvuo M. Use of the levonorgestrel_releasing intrauterine system and breast … -
List item
Press release: PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks
PRAC, Last updated: 11/10/2013containing the progestogens levonorgestrel, norgestimate and norethisterone … containing the progestogens levonorgestrel, norgestimate and norethisterone … with that of CHCs containing levonorgestrel and norethisterone (also … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
CHMP, Last updated: 25/07/2014contraceptives containing levonorgestrel and ulipristal acetate … -
List item
National expert: Xavier Kurz, European Medicines Agency (updated)
- Declaration of interests - 39.63 KB | PDF
- Curriculum Vitae - 260.87 KB | PDF
-
List item
National expert: Grant Munkwase, European Medicines Agency (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 23.82 KB | PDF
-
List item
National expert: Miriam Taekema, Medical Products Agency (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 26.06 KB | PDF
containing ethinyl estradiol and levonorgestrel in healthy women: a double_blind … -
List item
Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September 2004
Last updated: 16/09/2004Community-wide review for Rigevidon (levonorgestrel and ethinylestradiol) from … Community-wide review for Rigevidon (levonorgestrel and ethinylestradiol) from … -
List item
Press release: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh
CMDh, Last updated: 30/05/2013contraceptives (COCs) containing levonorgestrel and may be similar to the … contraceptives (COCs) containing levonorgestrel and may be similar to the … than for COCs containing levonorgestrel and may be similar to the …